Job Description Summary

Quality Assurance leader for Infusion products platform, responsible for end to end quality systems, development quality and post market quality of the platform products.

Job Description

We are the makers of possible  

  

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Opportunity: Vice President, Quality Assurance, Infusion

Segment: BD Medical

Business: Medication Management Solutions (MMS)

Platform: Infusion Solutions

Role based in San Diego, CA

The Vice President, Quality for the MMS-based Infusion business will be responsible for leading pre and post market quality, including the developing, establishment and maintenance of the quality assurance and engineering programs, policies, processes, procedures and controls during design, development and transfer; ensuring that performance and quality of infusion products globally  conform to product requirements, established standards and regulations. This role will lead a team based in San Diego, CA and provide subject guidance for our Eysins, Switzerland and other global sites conducting design and development activities.

This role oversees a varied quality team and is tasked with defining and driving excellent Quality practices, aligned with The BD Way and Quality Management Systems, for:

• Design Assurance and DFX programs

• Design Quality Engineering, including sustaining design change activities

• Software Quality Engineering (embedded, applications and analytics)

• Cybersecurity Risk Management

• Reliability Engineering

• Human Factors Test Method Development and Validation Safety Assurance Case practices.

The Vice President, part of the Multi-functional Infusion Platform Team, will advocate for Quality and Compliance in the Medication Management Solutions (MMS) unit. 

The Vice President will ensure that people and processes within the global Design & Development Quality function are capable of active management and improvement of product quality and compliance.  As the San Diego site operates under a Consent Decree, the Vice President must align with the conditions outlined in the decree.  This position is responsible for significant portions of QMS and product remediation activities within the business. This position reports to the VP of MMS Quality Management and is on the succession path for functional leadership.

The Vice President, Quality Assurance, Infusion will help drive the MMS business strategy as follows:

• Product Risk Management – this position is responsible for the effectiveness of MMS Quality Management System and continued reduction of risks inherent in MMS products and services.  As such, defining and maintaining a comprehensive Risk Management Program for all products is required and for Safety Assurance Cases, where required.  Included here are full responsibility for software and cybersecurity quality practices. This role involves recognizing how design flaws can affect our collaborators through field feedback data and introducing measures to minimize and improve the quality.

• Design Controls Compliance — this position is responsible for ensuring the MMS Quality Management System elements affecting design and development are effective and efficient enabling risk control and reduction.  Compliance to requirements is a must.  This leader shall be proficient in the development of design process requirements and leading the organization through the necessary diligence and decisions related to conformance to those requirements throughout the product development life cycle.

• Design Excellence—While quality principles are well-founded in our industry, the position is responsible for identifying superior processes to enable compliance and suitable product quality levels.  Critical-To-Quality initiatives will be the driving force behind focusing this team on the critical characteristics of MMS products.

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